K252249
- 510(k) number
- K252249
- Device name
- Extremity CT Imaging System
- Applicant
- Mars Bioimaging , Ltd. NZ
- Product code
- JAK — System, X-Ray, Tomography, Computed
- Decision date
- 2026-03-13
- Date received
- 2025-07-18
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Radiology
PDFDownload 510(k) SummaryArchived here · 0.4 MB · U.S. public domain
Also available from FDA: K252249.pdf
Official FDA record: K252249
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.